Clinical trials: Infections, Rotavirus
Rotavirus Infections
CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults
This is a study of CDC-9 inactivated rotavirus vaccine (IRV) microneedle patch (MNP) for intradermal administration in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series.
- Trial name
- NCT06962904
- Testing
- 3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV), 7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Infections, Rotavirus
A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia
This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the primary care settings of both Bulgaria and Latvia in children less than 5 years of age.
- Trial name
- NCT01733849
- Testing
- Stool sample, Data collection
- Where
- 57 sites in Bulgaria, Latvia
- Volunteers
- 1,266 people
- Sponsor
- GlaxoSmithKline
Pediatric Gastroenteritis
Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031).
This is a 1-year study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children < 5 years of age, conducted in four hospitals located in four Brazilian regions.
- Trial name
- NCT01195844
- Testing
- Rotavirus Vaccine
- Volunteers
- 230 people
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Rotavirus
Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.
This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously…
- Trial name
- NCT00729001
- Testing
- Human Rotavirus Vaccine - two different formulations, Prevnar, IPOL
- Volunteers
- 529 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India
Rotavirus disease is the most common cause of gastroenteritis and dehydration in young children worldwide. The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by…
- Trial name
- NCT00289172
- Testing
- Live attenuated human rotavirus vaccine
- Where
- 4 sites in India
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.
The main objectives of this study are: 1) In a subset (N = 20 000), to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.
- Trial name
- NCT00140673
- Testing
- Rotavirus
- Where
- 17 sites in Argentina, Brazil and 10 more
- Volunteers
- 63,227 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States
This observational cohort study, conducted through two existing large administrative health databases in the US (outside the Vaccine Safety Datalink) is planned to confirm the safety profile regarding lack of any association of…
- Trial name
- NCT00875641
- Testing
- Health Insurance Database
- Where
- United States
- Volunteers
- 390,659 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Gastroenteritis, Rotavirus Infections
Surveillance of Rotavirus Gastroenteritis in Children <5 Years
The purpose of this study is to monitor diarrheal disease and observe changes after the introduction of the rota vaccine.
- Trial name
- NCT01363726
- Where
- Israel
- Volunteers
- 30,000 people
- Sponsor
- Soroka University Medical Center
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least…
- Trial name
- NCT00750893
- Testing
- Rotarix or Rotarix liquid formulation
- Where
- South Korea
- Volunteers
- 3,111 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus, Rotavirus Vaccines
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the…
- Trial name
- NCT00353366
- Testing
- Rotarix, Data collection
- Where
- 18 sites in Philippines
- Volunteers
- 1,439 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Infections, Rotavirus Vaccines
Safety and Immunological Efficacy of the Pentavalent Rotavirus Vaccine - Rota-V-Aid™ (Live Attenuated Oral, Freeze-dried) at Healthy Adults Aged 18 to 45 Years.
The purpose of the presented study was to evaluate the safety and immunological efficacy in preventing the rotavirus infection within a cohort of healthy subjects (target age of 18-45 years old) by using the pentavalent rotavirus…
- Trial name
- NCT05037435
- Testing
- The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)
- Where
- Russia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Limited Liability Company Pharm Aid
Rotavirus Infection, Viral Gastroenteritis Due to Rotavirus
Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
The purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.
- Trial name
- NCT01328925
- Testing
- Nitazoxanide
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Romark Laboratories L.C.
Infections, Rotavirus
Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotarix Vaccination
This study aims to estimate the clinical and cost impact of Rotarix vaccinations among children aged less than 5 years using insurance claims data from commercial plans and Medicaid low-income population.
- Trial name
- NCT01915888
- Testing
- Data interpretation
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Immunity to Oral Rotavirus Vaccine, Immunity to Oral Polio Vaccine
Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Background: Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries.
- Conditions
- Immunity to Oral Rotavirus Vaccine, Immunity to Oral Polio Vaccine, Shedding of Oral Rotavirus Vaccine
- Trial name
- NCT01616693
- Testing
- Probiotic, Zinc, Rotavirus vaccine
- Where
- India
- Volunteers
- 620 people, healthy volunteers welcome
- Sponsor
- PATH
Infections, Rotavirus
Study of 2 Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis
Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than…
- Trial name
- NCT00134732
- Testing
- Live attenuated human rotavirus vaccine
- Where
- 6 sites in South Korea
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Infection
Safety and Preliminary Immunogenicity Study of Inactivated Vaccine for Prevention of Rotavirus Infection
This study is a randomized, double-blinded, placebo-controlled, Phase 1, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of Inactivated Rotavirus Vaccine (IRV) performed in healthy adult (aged…
- Trial name
- NCT04626856
- Testing
- Low dosage IRV on a 0- and 28-day schedule, Medium dosage IRV on a 0- and 28-day schedule, High dosage IRV on a 0- and 28-day schedule
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chinese Academy of Medical Sciences
Infections, Rotavirus
To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines
The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.
- Trial name
- NCT00140686
- Testing
- Rotavirus (vaccine)
- Where
- 101 sites in Czechia, Finland and 4 more
- Volunteers
- 3,994 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Study to Evaluate the Safety of Rotarix™ in Chinese Children
The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy children aged 2 to 6 years in China.
- Trial name
- NCT01086436
- Testing
- Rotarix ™
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Infections
Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam
An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam.
- Trial name
- NCT03367559
- Testing
- ROTAVAC®
- Where
- Vietnam
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
Infections, Rotavirus
Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™
The aim of this study is to monitor any impact in the change from the lyophilised formulation to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus gastroenteritis.
- Trial name
- NCT01435967
- Testing
- Data collection
- Where
- 8 sites in Belgium
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline